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Cited 17 time in webofscience Cited 18 time in scopus
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Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: A randomized controlled trialopen access

Authors
Han, Kyung-AhChon, SukChung, Choon HeeLim, SooLee, Kwan-WooBaik, SeiHyunJung, Chang HeeKim, Dong-SunPark, Kyong SooYoon, Kun-HoLee, In-KyuCha, Bong-SooSakatani, TaishiPark, SumiLee, Moon-Kyu
Issue Date
Oct-2018
Publisher
WILEY
Keywords
DPP-4 inhibitor; ipragliflozin; Korean; randomized controlled trial; SGLT2 inhibitor; type 2 diabetes mellitus
Citation
DIABETES OBESITY & METABOLISM, v.20, no.10, pp.2408 - 2415
Indexed
SCIE
SCOPUS
Journal Title
DIABETES OBESITY & METABOLISM
Volume
20
Number
10
Start Page
2408
End Page
2415
URI
https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/2675
DOI
10.1111/dom.13394
ISSN
1462-8902
Abstract
Aim: To evaluate the efficacy and safety of ipragliflozin vs placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). Methods: This double-blind, placebo-controlled, multi-centre, phase III study was conducted in Korea in 2015 to 2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT). Results: In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90 (0.69)% for ipragliflozin add-on and 7.92 (0.79)% for placebo. The corresponding mean (SD) changes from baseline to EOT were -0.79 (0.59)% and 0.03 (0.84)%, respectively, in favour of ipragliflozin (adjusted mean difference -0.83% [95% CI -1.07 to -0.59]; P < .0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0% (44.4% vs 12.1%) and < 6.5% (12.5% vs 1.5%) at EOT (P < .05 for both). Fasting plasma glucose, fasting serum insulin, body weight and homeostatic model assessment of insulin resistance decreased significantly at EOT, in favour of ipragliflozin (adjusted mean difference -1.64 mmol/L, -1.50 mu U/mL, -1.72 kg, and -0.99, respectively; P < .05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4%; placebo: 50.0%). No previously unreported safety concerns were noted. Conclusions: Ipragliflozin as add-on to metformin and sitagliptin significantly improved glycaemic variables and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM.
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